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Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults

13. oktober 2021 oppdatert av: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of High-Dose Live Recombinant Canarypox ALVAC-HIV Vaccine (vCP1452) in Healthy, HIV-1 Uninfected Adult Participants

The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine. This trial is designed to determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune response.

As of May 2001, over 200 people received the ALVAC-HIV (vCP1452) vaccine at the lower dose. The higher dose of the vaccine to be used in this study has not been given to humans previously. High doses of a similar vaccine have been given to a few people without serious side effects. In a recent study done in mice, higher doses of ALVAC-HIV produced stronger immune responses. It is possible that the doses of ALVAC-HIV given to humans are below the amount needed for the maximum immune response. Because the exact relationship between an increased immune response and its effectiveness in preventing HIV infection is uncertain, the HVTN will use the highest dose that can be manufactured.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

To date, adverse reactions to immunization with the various ALVAC-HIV candidate vaccines, including ALVAC-HIV (vCP1452), have been similar to those observed in healthy adults who have received other licensed vaccines of similar types. In a previous trial, even high doses of recombinant ALVAC vaccine were well tolerated in a group of participants that were significantly immunocompromised. In a recent study done in mice concerning dose escalation using the ALVAC-HIV vectors, the data demonstrated more robust immune responses with higher doses of ALVAC-HIV (vCP1452) in mice. It is certainly possible that the doses of ALVAC-HIV given to humans are well below the amount needed for a maximal cytotoxic T lymphocyte (CTL) response. As the predictive value of a CTL response is at present unknown with respect to its efficacy in preventing or ameliorating HIV acquisition or infection, the HVTN will utilize the highest dose that can be currently manufactured.

All study products are to be administered intramuscularly. Participants will receive 1 of 3 injections. Group A will receive a high dose of vaccine, group B will receive a low dose of vaccine, and group C will receive a placebo. Participants are inoculated at 4 time points. Assessment of product safety includes clinical observation, monitoring of hematological, chemical, and immunologic parameters, and a social harms questionnaire. Safety will be evaluated by monitoring of participants for local and systemic adverse reactions during the course of the trial. Participants will be monitored longitudinally for HIV-specific serologic and cellular immune responses.

Studietype

Intervensjonell

Registrering (Faktiske)

110

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • Alabama Vaccine CRS
    • California
      • San Francisco, California, Forente stater, 94102
        • San Francisco Vaccine and Prevention CRS
      • San Francisco, California, Forente stater
        • UCSF, Gen. Clinical Research Ctr., Mt. Zion Hosp.
    • Maryland
      • Baltimore, Maryland, Forente stater
        • Project Brave HIV Vaccine CRS
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Brigham and Women's Hosp. CRS
      • Boston, Massachusetts, Forente stater, 02115
        • Fenway Community Health Clinical Research Site (FCHCRS)
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63110
        • Saint Louis Univ Health Sciences Ctr
    • New York
      • New York, New York, Forente stater, 10021
        • NY Blood Ctr./Union Square CRS
      • Rochester, New York, Forente stater, 14642
        • Univ. of Rochester HVTN CRS
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02906
        • Miriam Hospital's HVTU
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt Vaccine CRS
    • Virginia
      • Annandale, Virginia, Forente stater
        • Infectious Diseases Physicians, Inc.
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • FHCRC/UW Vaccine CRS

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria

Participants may be eligible for this study if they:

  • Are between the ages of 18 and 60.
  • Are in good general health.
  • Have a CD4 count of 400 or more cells/mm3.
  • Do not have hepatitis C or active hepatitis B.
  • Have had a negative HIV blood test within 8 weeks prior to enrollment.
  • Use approved methods of contraception.
  • Have access to a participating site and are available for follow-up for 18 months.
  • Complete a questionnaire evaluating the participant's understanding of the study prior to enrollment.
  • Give written informed consent.

Exclusion Criteria

Participants may not be eligible for this study if they:

  • Are pregnant or breast-feeding.
  • Have received a live vaccine within 30 days prior to enrollment.
  • Have received a killed vaccine or allergy treatment with injections within 14 days prior to study vaccine.
  • Have used experimental research agents within 30 days prior to enrollment.
  • Have received HIV-1 vaccines or placebo in a previous HIV vaccine trial.
  • Have received blood products 120 days before HIV screening.
  • Have received immunoglobulin 60 days before HIV screening.
  • Have a history of serious harmful reactions to vaccines.
  • Have a history of disease of the immune system.
  • Have a history of cancer, unless it has been surgically removed and in the estimate of the investigator is not likely to happen again during the study period.
  • Are using or have used (within past 6 months) drugs that interfere with the immune system.
  • Have a history of type I or type II diabetes.
  • Have thyroid disease.
  • Have unstable asthma.
  • Are currently taking preventive anti-TB therapy.
  • Have a seizure disorder.
  • Have a bleeding disorder that was diagnosed by a physician.
  • Have had their spleen removed.
  • Have angioedema with serious episodes.
  • Have active syphilis.
  • Have hypertension.
  • Have mental problems that would interfere with the protocol.
  • Have any other problems that, in the judgment of the investigator, would interfere with the study.
  • Have a body mass index less than 20.
  • Are allergic or sensitive to egg products.
  • Have active tuberculosis.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Masking: Dobbelt

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Etterforskere

  • Studiestol: Paul Goepfert

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiet fullført (Faktiske)

1. desember 2005

Datoer for studieregistrering

Først innsendt

29. november 2001

Først innsendt som oppfylte QC-kriteriene

29. november 2001

Først lagt ut (Anslag)

30. november 2001

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. oktober 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HVTN 039
  • 10200 (Annen identifikator: CTEP)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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